The Recall Desk
HighFDA (Devices)·Z-1129-2023·Announced 2023-02-22

HydroMID 4Fr Catheters Recalled for Incorrect Expiration Dating

Access Vascular is recalling select lots of HydroMID 4Fr catheters because they are labeled with incorrect expiration dates—the devices expire before the labeled dates. This creates a risk of using expired medical equipment in clinical settings.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a mislabeling of expiration dates on medical devices, creating a risk-of-harm situation where users could unknowingly use expired equipment. No illnesses or injuries have been reported, aligning with the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Access Vascular, Inc. is recalling select lots of HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002. These catheters are labeled with expiration dates that exceed the actual expiration date of the devices.

Using an expired medical device poses a safety risk, as the device may not function as intended. This labeling error could result in the unintended use of expired catheters in a clinical setting.

Approximately 1,789 affected devices have been distributed nationwide to healthcare facilities in Connecticut, Illinois, Indiana, Massachusetts, Nebraska, Tennessee, and Texas. The affected lot numbers are 11428361, 11393260, and 11395226.

As of the recall announcement, no injuries or illnesses have been reported.

The recalled product

Product
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Manufacturer
Access Vascular, Inc
Category
Medical Device — Catheter / Vascular Access
Hazard
Affected units
1,789

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • UDI-DI: (01)00850030354006
  • Lot Number: 11428361
  • 11393260
  • 11395226

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Access Vascular, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Access Vascular, Inc

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Same hazard · expiration date mislabeling

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